FDA.reportPublic FDA data

HLS KneeTec

Primary DI
05056139226052
Brand
HLS KneeTec
Company
CORIN LTD
Model
MGG040
Catalog number
MGG040
Device description
Autodrilling pin dia 3,5mm Lg 50mm
Published
2018-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K094013000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K094013000HLS KNEETEC SYSTEMTornier2011-05-05JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056139226052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056139226052050561392260525056139226052

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+330456608978severine.siracusa@coringroup.c
+330456608978severine.siracusa@coringroup.com

Regulatory Flags#

DUNS number
295437313
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056139244933Apollo KneeTKR.BB.14022025-04-07
05056139244940Apollo KneeTKR.BB.14032025-04-07
05056139244971Apollo KneeTKR.IN.16002025-04-07
05056139244988Apollo KneeTKR.IN.17002025-04-07
05056139244995Apollo KneeTKR.BB.17002025-04-07
05056139245008Apollo KneeTKR.BB.17012025-04-07
05056139245015Apollo KneeTKR.BB.17022025-04-07
05056139245022Apollo KneeTKR.BB.17032025-04-07
05056139245039Apollo KneeTKR.BB.17042025-04-07
05056139245053Apollo KneeTKR.BB.17052025-04-07
05056139245060Apollo KneeTKR.BB.17062025-04-07
05056139245077Apollo KneeTKR.BB.17072025-04-07
05056139245145Apollo KneeTKR.IN.18002025-04-07
05056139245176Apollo KneeTKR.BB.15002025-04-07
05056139245718Apollo KneeTKR.IN.14002025-04-07
05056139245770Apollo KneeTKR.BB.11002025-04-07
05056139245787Apollo KneeTKR.BB.11012025-04-07
05056139245794Apollo KneeTKR.BB.11022025-04-07
05056139245800Apollo KneeTKR.BB.11032025-04-07
05056139245817Apollo KneeTKR.BB.12002025-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982533663ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
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00193982533694ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533700ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533717ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533724ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533731ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533748ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533861ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533878ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533885ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533892ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533908ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533915ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533922ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533939ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982533946ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982677428ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982677435ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982677442ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00193982677459ACTIFY 3DGLOBUS MEDICAL, INC.JWH2026-08-14
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
03701089509695AMPLITUDEAMPLITUDE SASJWH2026-07-31
03701089517492TRAXAMPLITUDE SASJWH2026-07-29
03701089517508TRAXAMPLITUDE SASJWH2026-07-29